Check-Cap shares surge 11.11% intraday after FDA grants C-Scan study exemption for colorectal polyp screening.

Check-Cap surged 11.11% intraday after receiving U.S. Food and Drug Administration (FDA) approval to conduct a study of its C-Scan polyp screening test. The investigational device exemption allows the company to evaluate the safety and efficacy of the ultralow-dose x-ray capsule, designed for colorectal polyp detection in average-risk patients unsuitable for colonoscopy. The regulatory milestone advances C-Scan’s development, enhancing its potential for commercialization and addressing unmet needs in colorectal cancer screening, which directly aligns with the stock’s sharp intraday rally.